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Pain Med Recall Includes Children’s OTC Product


November 08, 2019

Taro Pharmaceuticals USA Inc. is recalling dozens of lots of prescription ibuprofen and over-the-counter children’s ibuprofen. According to the November 6, 2019, US Food and Drug Administration (FDA) Enforcement Report, the oral suspension products may contain plastic particles.  

The recall affects the following products, which were distributed throughout the United States:

  • prescription ibuprofen oral suspension, 100 mg/5 mL (NDC 51672-1385-8), 4 fluid ounces (118 mL), distributed by Taro Pharmaceuticals USA from lots K779030125 (Exp. 10/19); D873031376 (Exp. 3/20); J871233188 (Exp. 9/20); L866934047 (Exp. 11/20); A973134376 (Exp. 12/20); and D967635229 (Exp. 3/21);  
  • prescription ibuprofen oral suspension, 100 mg/5 mL (NDC 51672-1385-9), 1 pint (473 mL), distributed by Taro Pharmaceuticals USA from lots J78402968 and J784129698 (Exp. 9/19); K765129698, K765229698, K765329698, K769329698, K778829698, and K778929698 (Exp. 10/19); A887230568, A887330568, and A887430568 (Exp. 12/19); B865430568, B865530568, B865630568, B869530568, and B869630568 (Exp. 1/20); D866431198, D866531198, D866631198, D866731198, D866831198, D866931198, D872631198, D872731198, D872831198, D872931198, and D873031834 (Exp. 3/20); E875331834, E875431834, E883831834, E883931834, E884031834, and E884131834 (Exp. 4/20); F865131834 (Exp. 5/20); G879432436, G879532436, G879632436, G879732436, G879832436, G879932436, G881632436, and G882232436 (Exp. 6/20); H865232436, H865332436, and H870832436 (Exp. 7/20); I885233156, I885333156, I885433156, I885533156, I885633156, and I885733164 (Exp. 8/20); J868533164, J868633164, J868733164, J868833164, J868933164, and J869033164 (Exp. 9/20); L866434042, L866534043, L866634044, L866734045, L866834046, and L866934422 (Exp. 11/20); A973134748, A973234423, A973334424, A979534425, A979634426, A979734427, and A979834428 (Exp. 12/20); and B974034749, B974134750, B974234751, B974334752, and B974434753 (Exp. 1/21); 
  • over-the-counter children's ibuprofen oral suspension, 100 mg/5 mL (NDC 51672-2130-8), berry flavor, dye-free, alcohol-free, 4 fluid ounces (120 mL), distributed by Taro Pharmaceuticals USA from lots E875131667 and E875231667 (Exp. 4/20); J871033189 and J871133189 (Exp. 9/20); and A972934375 and A973034375 (Exp. 12/20); 
  • over-the-counter children's ibuprofen oral suspension, 100 mg/5 mL (NDC 51672-2130-1), berry flavor, dye-free, alcohol-free, 8 fluid ounces (240 mL), distributed by Taro Pharmaceuticals USA from lot J871033187 (Exp. 9/20); and 
  • over-the-counter children's ibuprofen oral suspension, 100 mg/5 mL (NDC 67091-321-04), berry flavor, dye-free, alcohol-free, 4 fluid ounces (120 mL), distributed by WinCo Foods from lot A972834374 (Exp. 12/20).

Taro Pharmaceuticals USA voluntarily initiated the recalls September 27, 2019. The FDA designated them Class II on November 5, 2019. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists. 

Ibuprofen is a nonsteroidal anti-inflammatory medication used to treat pain and fever.

Jolynn Tumolo

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